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Shift: DayAbout Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
About the Role: We are seeking a Medical Writer to join our team in the Office of Medical Affairs. The writer will be primarily responsible for creating and updating regulatory documents for medical devices required by applicable regulations. These documents include Clinical Evaluation Plans (CEP), Literature Search Protocols, Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) plans, Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and other post-market reports.
This is a remote position, and you can work from home in most locations within the United States.
- Write, edit, and review reports
- Manage projects
- Gather appropriate input from stakeholders, and analyze relevant data
- Collaborate on decisions, facilitate document review process, and meet deadlines
- Work with product teams across one or more therapeutic application areas to develop and/or update product-specific regulatory documents
- Complete documents in accordance with internal procedures/templates and external guidelines and regulations
- Maintain compliance with training expectations
- Perform additional responsibilities as required within the scope of the position
Required Qualifications:
- Bachelor’s degree plus a minimum of 3 years experience in medical writing and/or regulatory writing, OR an advanced degree in a health-related field
- Demonstrated experience in critical and written analysis of medical literature, clinical data, or relevant documents for regulatory submissions
- Excellent computer skills including MS Office (Word, Excel, PowerPoint)
- Highly organized, self-motivated, and extremely detail-oriented
- Excellent written and verbal communication skills
- Proven ability to work independently with minimal supervision, meet deadlines, and manage multiple projects simultaneously
- Ability to collaborate across departments and relate effectively to people at all levels of the company
- Ability to travel up to 5%
Desired Qualifications:
- Training and degree in science, engineering, or medical field
- Prior experience in the medical device and/or pharmaceutical industry
- Experience with writing document types specific to the role or experience with regulatory writing relevant to the role, and familiarity with EU Medical Device Regulation 2017/745 (MDR)
